1. Field of the Invention
This invention relates to a connector for medical tubing for use in liquid transfer and a medical solution bag device using the connector. More particularly, this invention relates to a connector for medical tubing used in transfusion of medicinal solution and blood or in dialysis of body fluids through the medium of tubes and a catheter, which permits two tubes or a tube and a catheter to be connected with perferct water tightness so that the tubes and the catheter so connected may provide a perfect barrier against invasion of microorganisms such as bacteria and viruses into the tubing through the portions of their connection and to a medical solution bag device, particularly transfusion bag means proper for peritoneal dialysis, using the connector.
2. Description of Prior Art
In the continuous therapy as by peritoneal dialysis, transfusion of medicinal solution or transfusion of blood, perfect protection of the tubing used in the therapy against invasion of microorganisms through the point of connection between two tubes or between a tube and a container or catheter constitutes a technical task.
In the therapy by dialysis, particularly peritoneal dialysis which is directed to the regions within the abdominal cavity which are totally destitute of defense against microorganic attacks, safe protection of the tubing used in the therapy against the microorganic invasion constitutes one absolutely essential technical task. The recent therapy by peritoneal dialysis is less complicate in mechanism and construction and notably less expensive than the conventional therapy by dialysis using an artificial kidney. The medical science has substantially elucidated the causes for periotoneal adhesion. Thus, the therapy of the latest development is capable of effectively precluding the peritoneal adhesion and lightening the burden on the patient to a great extent. Besides, a system for continuous ambulatory peritoneal dialysis which enables the patient to engage normally in his daily work and, at the same time, receive continued therapy has been invented and adapted perfectly for practical use. Thus, the therapy by peritoneal dialysis has come to reawaken and maintain deep interest. The reliability of the this particular method of dialysis regarding the safety of patient depends on the question as to whether or not the microorganic invasion of the tubing used in the dialysis can be perfectly prevented and, consequently, the plight of complicated peritonitis due to propagation of microorganisms within the peritoneum can be precluded. Unfortunately, it is held that the method of dialysis in its existing level is not capable of prolonged use.
The conventional method for continuous ambulatory peritoneal dialysis will be specifically described below. A catheter is surgically inserted into the abdominal cavity of a patient. A connector is attached to the external end of this catheter. With this connector, the other connector attached to the free end of a transfusion tube is coupled. Injection of a dialytic solution into the abdominal cavity is accomplished by hanging a bag containing the dialytic solution from a place higher than the abdominal cavity, piercing into the discharge port of the bag a bag syringe attached to the leading end of the transfusion tube, and loosening a clamp attached halfway along the length of the tube and fastened to stop up the passage within the tube. After the injection of the dialytic solution into the abdominal cavity is completed, the aforementioned clamp is tightened on the tube and the tube is properly rolled into a coil, and the bag is stowed neatly at the waist of the patient. Then, the patient is now free to walk around and engage in his normal work. After lapse of a stated length of time, the spent dialytic solution is withdrawn from the abdominal cavity. This withdrawal is effected by extending the tube, placing the bag on the floor, for example, and loosening the clamp on the tube. Then, the bag syringe is pulled out of the bag and the bag now containing the spent dialytic solution is discarded. The next dialysis is effected by setting a new bag containing fresh supply of dialytic solution at a high level and then piercing the bag syringe into the transfusion port of the new bag. This procedure is repeated for the third and following cycles of dialysis.
At present, whenever the connectors are coupled and the bag syringe is inserted into the discharge port of the bag in preparation for the first cycle of dialysis and each of the following cycles of dialysis, disinfecting works such as immersing the connectors momentarily in the solution of an iodine-based bactericide and thoroughly wiping the tip of the bag syringe with the bactericide are executed in order to prevent microorganic invasion of the tube interior. The bactericide in the solution enters the patient's body, though in a very small amount, and acts as a harmful substance. Thus, the bactericide is not allowed to be used in a high concentration but is required to be used in an extremely low concentration.
There has been also proposed equipment for continuous ambulatory peritoneal dialysis using a solution container connected by a flexible tube to a pateint's tube leading into the patient's abdominal cavity, which equipment comprises a flexible, foldable plastic container for dialytic solution provided with a transfer port extended therefrom, a flexible tube extended from the aforementioned transfer port and provided at the leading end thereof with a luer connector for connection to a luer connector attached to the patient's tube, and a breakable member provided in the aforementioned flexible tube and adapted to obstruct the flow of the solution within the tube until it is broken (Japanese Publication of Unexamined Patent Application No. 55-99257, corresponding to United Kingdom Patent Application GB Nos. 2,040,379A and 2,063,684A). This equipment also requires the leading ends of the tubes to be immersed in the bactericide or wiped thoroughly with the bactericide before it is put to use. By the same token, this equipment has a similar disadvantage.
The disinfecting works involved in the conventional devices, therefore, fall short of being justly called sterilization from the microorganic point of view. In fact, many cases of infection occurring through connectors and bag syringes on lapse of about two months' time after the start of dialysis and rounding up in complication with peritonitis have been reported. At present no effective measure is available for preventing this infection. Although the continuous ambulatory peritoneal dialysis proves to be a highly effective form of therapy as described above, it is held that this therapy cannot be safely performed for a long time.